Recommending a Strategy

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Yale Access to Knowledge Conference
Access to Medicines India TRIPS
by Dilip Shah CEO-Vision Consulting
Group www.vision-india.com
Yale Law School, New Haven April 21-23, 2006


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Access to Medicines
Outline of Presentation

• Pharmaceutical Market
• Implementation Impacting Access
• New Initiatives Creating Barriers to Access
• What Must India Do?
• Where Do the Problem Lie?
• What to Do About It?

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Access to Medicines
Pharmaceutical Market
World Audited Market - 2005
7.1
Source IMS Health MIDAS, MAT March 2005
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Access to Medicines
Pharmaceutical Market

• Generics Size and Growth (Billions)

2001-07 CAGR Overall 13.3 ROW
8.9 Europe 15.5 U S 13.6
Source Datamonitor
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Access to Medicines
Pharmaceutical Market
Generic Utilization by Country - 2004
Share Value/Volume
Source IMS Health MIDAS, MAT MARCH 2004
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Access to Medicines
Implementation Impacting Access

• Doha Declaration November 2001
• August 2003 Decision
• TRIPS Amendment November 2005
• Canada Limiting Scope
• India Creating Hurdle
• Rest of the World

Dilution of Flexibilities at Every Stage
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Access to Medicines
New Initiatives Creating Barriers to Access

• TRIPS-Plus FTAs
• Data Protection Beyond TRIPS Article 39.3
• Linking Regulatory Approval to Patent
• SPLT Harmonization of Patent Laws
• EC Criminalization of Patent Disputes
• US Bioshield II

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Access to Medicines
New Initiatives Creating Barriers to Access
FTAs Distorting Balance
Courtesy GPhA
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Access to Medicines
Harmonization of Patent Law - SPLT
TRIPS-Plus Agenda of WIPO

• Trilateral Want Four Issues on Fast Track
• Prior Art
• Grace Period
• Novelty
• Inventive Step
• Harmonization will Take Away Flexibilities
• to Design Own IP System
• A Move to Stall Generics in the World

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Access to Medicines
New Initiatives Creating Barriers to Access
Bioshield II Legislation

• Patent Extensions 10 Years or More
• Market Exclusivity Up to 10 Years for NCE,
• 6 Years for New Use
• International Protection for Bioshield
• IP Extraterritoriality

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Access to Medicines
What Must India Do?
PhRMA Mandate to USTR for India

• Modify Mandatory Compulsory Licensing for
• Mail Box Applications
• Adopt US Standards for Patentability and Scope
• of Patentable Subject Matter
• Abolish Pre-Grant Opposition
• Tighten Compulsory Licensing Provisions
• Seek Data Protection Beyond TRIPS Article 39.3

PhRMA Damage Estimate 3.5 Bn 78 of Indian
Market
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Access to Medicines
What Must India Do?
STAND-UP RESIST BUT WILL IT ?
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Access to Medicines
Where Do The Problem Lie?

• Quality of Patents
• Weakened Standards of Examination
• Lack of Pre-Grant Opposition
• Litigation Overtakes Innovation

Something Has Gone Wrong with the US Patent
System New York Times Editorial, 22 March 2006
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Access to Medicines
Where Do The Problem Lie?
Impact of IP Systems on Innovation
For the better part of two centuries, the US
patent system has driven Americas extraordinary
innovativeness. In the last two decades, however,
the system of laws that for so long fueled the
innovation engine has become sand in its gears.
Harvard Business Review - November 2004
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Access to Medicines
Where Do The Problem Lie?
Impact of IP Systems on Innovation
Source US FDA
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Access to Medicines
Where Do The Problem Lie?
Impact of IP Systems on Innovation
USA No of Patent Applications and Awards
Source Innovation Its Discontents by Jaffe
Lerner, Princeton, 2004
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Access to Medicines
Where Do The Problem Lie?
Impact of IP Systems on Innovation
USA No of Patent Suits Filed at District Level
Source Innovation Its Discontents by Jaffe
Lerner, Princeton, 2004
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Access to Medicines
Where Do The Problem Lie?

• Examples of Patenting in USA
• Polymorphs

• Polymorphs are substances with the same chemical
  formula and biological activity. However, the
  arrangement of the molecules in the crystal
  lattice differs, which may result in some
  physical characteristics like solubility, melting
  point and stability differing.

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Access to Medicines
Where Do The Problem Lie?

• Examples of Patenting in USA
• Polymorphs

Product Ribavarin (REBETOL) Innovator
Schering 1st Patent US 3,798,209
filed on 1 June 1971 Marketing Approval 3 June
1998 Polymorph Patent US 6,051,252 to
Schering on 18 April 2000 Claim 1 A Compacted
Ribavarin Composition Substantially free of
other Ribavarin Polymorphic Forms
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Access to Medicines
Where Do The Problem Lie?

• Examples of Patenting in USA
• Polymorphs

Product Donepezil Hydrochloride
(ARICEPT) Innovator Eisai 1st Patent
US 4,895,841 Filed on 20 June 1988 Marketing
Approval 25 November 1996 Polymorph Patent
US 6,140,321 to Eisai on 31 October 2000 Claim
1 Form III of Donepezil Hydrochloride, which is
the Marketed Form
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Access to Medicines
Where Do The Problem Lie?

• Examples of Patenting in USA
• Substantially Pure

Patents are often obtained for the compound
without any reference to purity. Thereafter, a
patent is sought for a Substantially Pure
compound. The later obtained patent becomes a
block for generic companies, as it is well known
that pharmaceutical products have to be
Substantially Pure.
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Access to Medicines
Where Do The Problem Lie?

• Examples of Patenting in USA
• Substantially Pure

Product Fexofenadine Hydrochloride
(ALLEGRA) Innovator Aventis 1st
Patent US 4,254,129 Filed on 10 April
1979 Marketing Approval 25 July 1996 Pure
Product Patent US 5,578,610 on 26 November
1996 Claim 1 Substantially Pure compound,
which is the product on the market
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Access to Medicines
Where Do The Problem Lie?
Examples of Patenting in USA Substantially Pure
Product Ondansetron Hydrochloride
(ZOFRAN) Innovator Glaxosmithkline
Compound Patent US 4,695,578 Filed on 17
November 1986 Marketing Approval 4 January
1991 Pure Product Appln WO 02/055492 A2 Filed
by Teva 11 January 2002 Claim 1
Ondansetron Hydrochloride having a purity of at
least 99.0 (Generic Companies are also
attempting to block other generic companies to
limit competition)
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Access to Medicines
What to Do About It?

• Restore Some Sanity to the US Patent System
• Seek Modifications to the US Patent Law
• Create Domestic Lobby to Restore Balance

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THANK YOU
dgshah_at_vision-india.com www.vision-india.com
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